Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-03-10 @ 11:28 PM
Study NCT ID:
NCT03216668
Status:
UNKNOWN
Last Update Posted:
2018-10-23
First Post:
2017-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012838', 'term': 'Silymarin'}], 'ancestors': [{'id': 'D044947', 'term': 'Flavonolignans'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Block randomization'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-20', 'studyFirstSubmitDate': '2017-07-09', 'studyFirstSubmitQcDate': '2017-07-11', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The absolute change after treatment discontinuation from week 6 to week 10 in ALT , compared between Tonka and Silymarin (Legalon)', 'timeFrame': 'week 6, week 10'}, {'measure': 'The absolute change after treatment discontinuation from week 6 to week 10 in AST , compared between Tonka and Silymarin (Legalon)', 'timeFrame': 'week 6, week 10'}, {'measure': 'The absolute change after treatment discontinuation from week 6 to week 10 in GGT , compared between Tonka and Silymarin (Legalon)', 'timeFrame': 'week 6, week 10'}, {'measure': 'The absolute change after treatment discontinuation from week 6 to week 10 in Total Bilirubin, compared between Tonka and Silymarin (Legalon)', 'timeFrame': 'week 6, week 10'}], 'primaryOutcomes': [{'measure': 'The percentage of patients with ALT reduced to less than or equal to 60 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'The percentage of patients with ALT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The percentage of patients with ALT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The percentage of patients with AST reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The percentage of patients with AST reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The percentage of patients with GGT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The percentage of patients with GGT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The percentage of patients with ALT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The percentage of patients with ALT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The percentage of patients with AST reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The percentage of patients with AST reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The percentage of patients with GGT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The percentage of patients with GGT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '3 weeks'}, {'measure': 'The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)', 'timeFrame': '6 weeks'}, {'measure': 'The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon).', 'timeFrame': '6 weeks'}, {'measure': 'The number of participants with clinically significant vital sign parameters at week 6, compared between Tonka and Silymarin (Legalon).', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Function Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy TONKA on the reduction of ALT and AST in moderate to severe liver enzyme elevated patients; compared with Silymarin (Legalon) after 6 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female more than 18 year old.\n* Diagnosed as Alcoholic Liver Disease (ALD), or Non Alcoholic Fatty Liver Disease (NAFLD), or Liver Function Disorders due to Drugs or Chemicals.\n* ALT at baseline is in between 150 U/L to 400 U/L\n* Sign the informed consent form\n\nExclusion Criteria:\n\n* Hepatitis B or C.\n* Pregnant or Lactating women'}, 'identificationModule': {'nctId': 'NCT03216668', 'briefTitle': 'TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nhat Nhat Pharmaceutical Company'}, 'officialTitle': 'A Randomized, Active-Control, Open Label, Phase IIIb Study to Evaluate the Safety and Efficacy of TONKA Compared With Silymarin (Legalon) for Lowering Hepatic Enzymes in Liver Function Disorder Patients With Moderate to High Elevated Liver', 'orgStudyIdInfo': {'id': 'TONKA-V3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TONKA', 'description': 'Administered orally twice a day, 2 tablets each time, for 6 weeks', 'interventionNames': ['Drug: TONKA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LEGALON', 'description': 'Administered orally three times a day, two tablets each time, for 6 weeks', 'interventionNames': ['Drug: LEGALON']}], 'interventions': [{'name': 'TONKA', 'type': 'DRUG', 'description': 'Administered orally twice a day, 2 tablets each time, for 6 weeks.', 'armGroupLabels': ['TONKA']}, {'name': 'LEGALON', 'type': 'DRUG', 'description': 'Administered orally three times a day, two tablets each time, for 6 weeks', 'armGroupLabels': ['LEGALON']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huế', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Phuong Tran, BA.', 'role': 'CONTACT', 'email': 'lienhe@nhatnhat.com', 'phone': '84.72.3817 117'}, {'name': 'Pham Nhu Hiep, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Phan Thi Minh Huong, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hue Central General Hospital', 'geoPoint': {'lat': 16.4619, 'lon': 107.59546}}], 'centralContacts': [{'name': 'Phuong Tran, BA', 'role': 'CONTACT', 'email': 'lienhe@nhatnhat.com', 'phone': '84.72.3817 117'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nhat Nhat Pharmaceutical Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}